Featured Articles
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products - What’s in the Clinic? (Part 3 – Pipeline)
Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and conclude this series of three articles, examining the past, present, and future of these products with the intent of understanding their whats and whys.
CONTAINER CLOSURE SYSTEMS - Application & Effectiveness of Daikyo Crystal Zenith® Container Closure Systems for Radiopharmaceuticals
Lloyd Waxman, PhD, and Vinod Vilivalam, PhD, believe a more promising application has been to label mAbs with a positron emitter for use in understanding the in vivo behavior and efficacy of targeted drugs in individual patients and for more effective drug development.
FORMULATION DESIGN - Formulation of Poorly Soluble Drugs: A Modern Simulation-Based Approach
Sanjay Konagurthu, PhD, and Alexander McVey, MS, present a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using molecular modeling combined with experimental data.
ADVANCED DELIVERY DEVICES - Wearable Bolus Injectors - A New Class of Patient-Friendly Drug Delivery Systems
Michael D. Hooven, MSME, indicates bolus injectors represent one of the most exciting new opportunities in the field of medical devices, and his company’s focus on developing innovative technology in combination with an intense emphasis on Human Factors has resulted in a system that is unique in a number of ways.
MANAGEMENT INSIGHT - The Biotech Bubble: What Goes Up Must Come Down
Physicists know it. Coffee drinkers live it. Roller coasters capitalize on it. Yet stock market investors - even coffee-drinking physicist-investors strapped into roller coasters -…
EXECUTIVE INTERVIEW - Norwich Pharma Services: Synchronized Outsourced Solutions for Contract Development & Manufacturing
Drug Development Executive: Kristin Arnold, PhD, Norwich’s VP of Product Development and Technical Services, talks about the company’s long history in pharmaceutical manufacturing, its evolution as a CDMO, the “perfect” client, and its role as a service provider from start to finish.
BUSINESS DEVELOPMENT - If You Are Not At Risk of Losing Your Job, Then You Are Probably Not Doing It Right!
John A. Bermingham believes too many companies today, and the people who run them, have developed a negative culture on responsible risk and believes with proper due diligence, success can be achieved.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
INTRAORAL DELIVERY - Utilization of Intraoral Administration for Enablement & Enhancement of Drug Delivery – Highlights of Recent Commercial Products
Zhen Yang, PhD, and Yunhui Wu, PhD, highlight several commercialized intraoral formulations from a clinical pharmacokinetic perspective and reveal its mechanism for enablement or enhancement of drug delivery via intraoral administration.
BUCCAL DELIVERY - Dissolvable Film Format Evolves to Buccal Drug Delivery Applications
Scott D. Barnhart indicates the buccal and sublingual oral mucosa will continue to be an area of growing interest for drug delivery as researchers evaluate ways to improve bioavailability, patient compliance, and product lifecycle beyond tablet and injectable formats.
ANTIBODY DRUG CONJUGATES - ADC Development Using SMARTag(TM) Technology
Robyn M. Barfield, PhD, and David Rabuka, PhD, say that despite challenges, there has been progress in advancing complex compounds through clinical trials and successfully treating patients, and these bioconjugate compounds include a subset of molecules known as ADCs.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 2 – Analysis)
Tugrul T. Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.
DISPOSABLE TECHNOLOGY - Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
EXECUTIVE INTERVIEW - Array BioPharma: Steadily Moving to Late-Stage Development, Preparing for Commercialization
Executive Summary: Ron Squarer, Chief Executive Officer of Array BioPharma, talks about the company’s pipeline and evolution into a fully integrated, commercial-stage biopharmaceutical company.
EXECUTIVE INTERVIEW - BioCellChallenge: Optimizing the Potential of Intracellular Therapeutic Antibodies
Drug Development Executive: Dr. Laurent Meunier, CEO of BioCellChallenge, discusses the development of a new liposomal formulation allowing the use of intracellular therapeutic antibodies.
BIOAVAILABILITY ENHANCEMENT - Diffusion of Innovation & the Adoption of Solubilization Technologies
Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.
BUSINESS DEVELOPMENT - Traffic Light Decision-Making
All of us have faced decisions in which, if we make the right decision, we are a hero, and if we make the wrong one,…
CELL THERAPIES - The Challenges & Possible Solutions for Transferring Cell Therapy From the Bench to the Industry
Lior Raviv, MMedSc, and Ohad Karnieli, PhD, discuss the significant emerging challenges in downstream processing of cell therapies focused mostly on allogeneic therapies.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 1 – Introduction)
Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD; believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.
EXECUTIVE INTERVIEW - Hermes Pharma: User-Friendly Dosage Forms, a Win-Win Situation for Patients & Pharma
Drug Development Executive: Dr. Thomas Hein, Director, Sales & Business Development at Hermes Pharma, discusses how user-friendly dosage forms help put patients first, their advantages for patients and pharmaceutical companies, as well as the challenges associated with their development and production.
